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Completed

NCT Number: NCT03105739

Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children

The purpose of this prospective, randomized study was to compare the incidence of adverse events associated with removal of the LMA either in deeply anesthetised or awake patients.

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Key information

Conditions

Laryngeal Mask Airway Removal Respiratory Complication

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital d'Enfants Béchir Hamza

Bab Saadoun, Tunis Governorate, 1029, Tunisia

About this study

Written informed consent was obtained from parents for this prospective, randomized study conducted on children scheduled for minor surgery. Anesthesia was induced with sevoflurane, supplemented with propofol (3mg/kg) then maintained with nitrous oxide and sevoflurane 2-4% in oxygen. Analgesia was insured by peripheral nerve blocks. Included children were randomized into 2 groups:

  • Awake: the LMA was left in place until the patient fully regained consciousness
  • Deeply anesthetised: the LMA was immediately removed once the halogenated anesthetic turned off, and ventilation using facial mask was carried until spontaneous ventilation recovery.

Respiratory complications that occurred during LMA removal until 20 minutes afterwards were recorded. Children with respiratory history and those for whom peripheral nerve blocks failed, were excluded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children scheduled for minor surgery

Exclusion criteria

  • None

Treatment and study plan

LMA removal

Other

According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.

Primary outcomes

  1. Occurence of respiratory adverse events

    Time frame: from LMA removal to 20 minutes afterwards

Sponsors and collaborators

Lead sponsor

Hôpital d'enfants Béchir-Hamza

Other

Registry information

Official study title

Timing of Withdrawal of the Laryngeal Mask Airway (LMA) in Children: Early or Late Removal?

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2017
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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